Hemostatic puncture closure system and method of use

ABSTRACT

A system, a closure, and method of use for sealing a percutaneous puncture in a blood vessel. The puncture includes an opening in the vessel wall and a tract leading to the opening. The system includes an introducer sheath and associated positioning device, a hemostatic puncture closure, and a deployment instrument. The positioning device enables the introducer sheath to be positioned at a desired position within the vessel. The deployment instrument includes a tubular carrier storing the closure. The closure comprises a rigid, e.g., radio-opaque, anchor, a compressed collagen plug, and a thin filament connecting the two in a pulley-like arrangement. The instrument and introducer are used to introduce the closure into the puncture, with the anchor located within the artery and with the collagen plug within the puncture tract. A locking member is provided to hold the closure in place at its operative position, whereupon hemostasis occurs rapidly, thereby sealling the puncture.

SPECIFICATION

This application is a Continuation of our earlier filed U.S. patentapplication Ser. No. 08/604,205 filed on Feb. 21, 1996 entitledHemostatic Puncture Closure System and Method of Use, now U.S. Pat. No.5,707,393, which in turn is a Continuation of our earlier filed U.S.patent application Ser. No. 08/426,371 filed on Apr. 21, 1995 entitledHemostatic Puncture Closure System and Method of Use, which in turn is aContinuation of our earlier filed U.S. patent application Ser. No.08/154,882 filed on Nov. 18, 1993, entitled Radio-opaque HemostaticPuncture Closure System and Delivery System Therefore, now U.S. Pat. No.5,441,517, which in turn is a Continuation of our earlier filed U.S.patent application Ser. No. 07/846,322 filed on Mar. 5, 1992, entitledHemostatic Puncture Closure System and Method of Use, now U.S. Pat. No.5,282,827, which in turn is a Continuation-In-Part of our earlier filedU.S. patent application Ser. No. 07/789,704, filed on Nov. 8, 1991,entitled Hemostatic Puncture Closure System and Method of Use, now U.S.Pat. No. 5,222,974, all of whose disclosures are incorporated byreference herein and which are assigned to the same assignee as thisinvention.

BACKGROUND OF THE INVENTION

In U.S. Pat. No. 5,021,059, which has been assigned to the same assigneeas this invention, there is disclosed a closure device and method of usefor sealing a small incision or puncture in tissue separating oneportion of the body of a living being from another portion thereof,e.g., a percutaneous puncture in a artery, to prevent the flow of a bodyfluid, e.g., blood, through the puncture. The closure device is arrangedto be used with (deployed by) an instrument which comprises a carrier inthe form of a tubular member. The tubular member has a proximallylocated portion and a distally located portion. The latter includes anopen free end arranged to be introduced through the incision orpuncture. The proximately located portion of the tubular member isarranged to be located out of the body of the being when the distallylocated portion is extended through the incision or puncture.

The closure device comprises three components, namely, an anchor member,a sealing member, and a filament, e.g., suture. The sealing member isformed of a hemostatic material, e.g., compressed collagen foam. Theanchor member includes a tissue engaging portion configured to passthrough the puncture in one direction but resistant to passagetherethrough in the opposite direction. The sealing member includes atissue engaging portion. The filament is connected between the anchormember and the sealing member in a pulley-like arrangement so that theymay be moved relative to each other by the application of a pullingforce on the filament.

The instrument is arranged to expel the anchor member through thepuncture, e.g., into the artery, and to draw its tissue engaging portioninto engagement with the tissue contiguous with the puncture. Thefilament extends through the instrument to a point outside the body ofthe being and is arranged to be drawn in the proximal direction,whereupon the portion of the filament connecting the anchor member andthe sealing member causes the tissue engaging portion of the sealingmember to move with respect to said anchor member and into engagementwith the tissue contiguous with the puncture on the opposite sidethereof from said anchor member. This action causes the tissue engagingportion of the sealing member to seal the puncture from the flow offluid therethrough.

The closure device and deploying instrument in that patent leavesomething to be desired from the standpoints of effectiveness andefficiency of use.

OBJECTS OF THE INVENTION

Accordingly, it is a general object of this invention to provide aclosure device and methods of use which overcomes the disadvantages ofthe prior art.

It is a further object of this invention to provide a system including aclosure, a deploying instrument, and method of use for quickly, easily,safely and effectively sealing a percutaneous puncture in a blood vesselwithin the body of a living being from another portion.

It is still a further object of this invention to provide devices andmethods for enabling one to radiographically image the closure duringits placement to seal a percutaneous incision or puncture in a bloodvessel and after such placement has been accomplished.

SUMMARY OF THE INVENTION

These and other objects of this invention are achieved by providing aclosure for use in a system for sealing a percutaneous incision orpuncture in a blood vessel. The system basically comprises carriermeans, introducer means, and closure means. The puncture comprises atract extending through tissue overlying the blood vessel. The closuremeans comprises anchoring means, sealing means, and filament means. Thefilament means is connected between the anchoring means and the sealingmeans. The introducer means comprises a tubular member having a distalfree end arranged to be inserted into the puncture tract and through thepuncture. The carrier means is arranged to be inserted through theintroducer means to expel the anchoring means therefrom and to draw theanchoring means into engagement with the distal free end of theintroducer means. The introducer means and the carrier means arearranged to be moved together to draw the anchoring means intoengagement with the interior tissue of the blood vessel contiguous withthe puncture. The filament means is arranged to pull the anchoring meansand the sealing means relative to each other to cause the sealing meansto engage tissue contiguous with the puncture outside of the vessel.

In accordance with one aspect of this invention the system includesmeans and a method of use to enable one to readily determine thelocation of the wall of the vessel or lumen by the percutaneousintroduction of such means into the vessel or lumen. Such means can beused as a part of the system or method to seal the puncture or incisionin a vessel or lumen or may be used for other purposes, e.g., it may beused for any application wherein it is desirable to determine thelocation of a vessel or lumen wall via a percutaneous incision orpuncture.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects and many of the attendant advantages of this inventionwill readily be appreciated as the same becomes better understood byreference to the following detailed description when considered inconnection with the accompanying drawings wherein:

FIG. 1 is a side elevational view, partially in section, showing adeploying instrument and a closure device of the system of the subjectinvention;

FIG. 2 is an enlarged top plan view of the closure device shown in FIG.1, with the sealing component shown in an uncompressed state;

FIG. 3 is a top plan view, like that of FIG. 2, but showing the sealingcomponent in its compressed state ready for deployment by the instrumentof FIG. 1;

FIG. 4 is an enlarged top plan view of the anchor component of theclosure device;

FIG. 5 is an enlarged side elevational view of the anchor component ofclosure device;

FIG. 6 is a greatly enlarged plan view showing the knot used to effectthe securement of a filament component of the closure device to thesealing component thereof;

FIG. 7 is a top plan view of one embodiment of a introducer sheathposition indicating device forming a portion of the system of thisinvention;

FIG. 8 is an enlarged sectional view taken along line 8--8 of FIG. 7;

FIG. 9 is a front elevational view of a torsion spring used with thedeployment instrument;

FIG. 10 is a side elevational view of the spring shown in FIG. 9;

FIG. 11 is an isometric view of the deployment instrument shown in FIG.1;

FIG. 12 is an illustration showing a preliminary step in the positioningof a conventional introducer sheath through a percutaneous puncture inan artery using the position indicating device shown in FIG. 7;

FIG. 13 is an illustration similar to that of FIG. 12 showing desiredposition of the introducer sheath within the artery as established bythe use of the position indicating device shown in FIG. 7;

FIG. 14 is an illustration showing the introduction of the deploymentinstrument into the properly located introducer sheath;

FIGS. 15-23 are illustrations, similar to FIGS. 11 and 12, but showingthe sequential steps in the use of the instrument to deploy the closuredevice to seal the percutaneous puncture in the artery;

FIG. 24 is an enlarged illustration showing the closure device in placeafter it has sealed the percutaneous puncture in the artery;

FIG. 25 is an isometric view of a position indicating clip of the systemof this invention;

FIG. 26 is an isometric view of a second embodiment of a introducersheath position indicating device forming a portion of the system ofthis invention;

FIG. 27 is an illustration similar to that of FIG. 12 showing desiredposition of a conventional introducer sheath within the artery asestablished by the use of the second embodiment of the positionindicating device shown in FIG. 26;

FIG. 28 is an isometric view of a third embodiment of a introducersheath position indicating device forming a portion of the system ofthis invention;

FIG. 29 is an illustration similar to that of FIG. 12 showing desiredposition of a conventional introducer sheath within the artery asestablished by the use of the third embodiment of the positionindicating device shown in FIG. 28;

FIG. 30 is an isometric view of a conventional dilator;

FIG. 31 is an isometric view of a modified introducer sheath forming aposition indicating device of the system of this invention;

FIG. 32 is an enlarged sectional view taken along line 32--32 of FIG.31;

FIG. 33 is an illustration similar to that of FIG. 12 showing desiredposition of the modified introducer sheath of FIG. 32 located within theartery;

FIG. 34 is an enlarged top plan view of an alternative anchor componentto that shown in FIG. 4;

FIG. 35 is an enlarged side elevational view of the alternative anchorshown in FIG. 34;

FIG. 36 is an enlarged sectional view of an alternative tamping means tothat shown in FIG. 1;

FIG. 37 is an enlarged illustration similar to FIG. 23 but showing theuse of the alternative tamping means of FIG. 36; and

FIG. 38 is an enlarged illustration similar to FIG. 24 but showing theclosure device in place after it has sealed the percutaneous puncture inthe artery using the alternative tamping means.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now in greater detail to the various figures of the drawingswherein like reference characters refer to like parts, there is shown at20 an instrument forming a portion of a system for deploying a closuredevice 22 to seal a percutaneous puncture 24 within a blood vessel 26,e.g., the femoral artery, constructed in accordance with this invention.The puncture 24 includes not only the opening in the wall of the vesselbut also the tract 24A, i.e., the passageway in the tissue locatedbetween the vessel and the skin of the being formed when the vessel ispunctured.

The instrument 20 and closure device 22 have particular utility whenused in connection with intravascular procedures, such as angiographicdye injection, cardiac catheterization, balloon angioplasty and othertypes of recanalizing of atherosclerotic arteries, etc. since theclosure 22 is designed to cause immediate hemostasis of the bloodvessel, e.g., arterial, puncture. However, it is to be understood thatwhile the description of the preferred embodiment instrument and closurecontained herein is directed to the closing off of percutaneousincisions or punctures in arteries, they have much more wide-spreadapplications. Thus, the sealing of a percutaneous opening in an arteryshown herein is merely exemplary.

Before describing the closure 22 and the instrument 20 for inserting itto seal the opening, a brief description of a typical, conventional,intravascular surgical procedure, e.g., catheter instrumentation of anartery, utilizing a percutaneous opening will be given to bestappreciate the features of the invention. In such a procedure a cannulaof an instrument, such as an angiographic needle (not shown), isinserted percutaneously through the skin into the artery, such as thefemoral artery, at the situs for the instrument's insertion. The needlecannula is held in place and the flexible end of a mini-guidewire (notshown) is then passed through the cannula into the artery to the desireddepth (i.e., longitudinal position therealong). Once the mini-guide wireis in place the needle cannula is removed, leaving the guidewire inplace. An introducer sheath 28 (FIGS. 12 and 13 ) and an arterialdilator (not shown) are then passed over the guidewire, through thepuncture or incision and into the artery. The guidewire and then thedilator are removed leaving the introducer sheath in place. A catheter,or other intravascular instrument (not shown) is then inserted throughthe introducer sheath 28 and threaded down the artery 26 to the desiredintravascular location, e.g., the situs of the atheroscleroticocclusion.

Once the intravascular procedure (e.g., angioplasty) has been completed,the catheter is removed. Thereafter, the sheath is removed and thesurgeon or other trained person applies manual, digital pressure to thepercutaneous puncture until hemostasis has occurred. In particular, thecurrent standard of care for puncture hemostasis is to apply digital ormechanical pressure on the puncture site for twenty minutes to an hour,depending on the puncture size and the degree of hemolytic therapy.Obviously this results in wasted time for the physicians and othercatheter lab personnel, and causes inconvenience and discomfort for thepatient. In addition serious complications arise from persistentbleeding and hematoma formation in approximately five percent of thepatients.

In accordance with the method of this invention the introducer sheath 28is left in place within the artery (although it is moved so that itsdistal end is at a desired position therein, as will be describedlater). The deployment instrument 20 having the closure device 22therein is inserted into the introducer sheath. The closure device isthen deployed (ejected) and operated to immediately seal the arterialpuncture site 24 and plug the tract 24A. Moreover, as will beappreciated from the description to follow the closure device 22 isdesigned to reduce post-procedure puncture complications, cause minimalinflammatory reaction and resorb completely within a relatively shortperiod of time, e.g., sixty to ninety days.

The details of the closure 22 and instrument 20 for introducing it willbe described in detail later. Suffice it for now to briefly describe theclosure and its method of deployment and use. Thus, as will be seenlater the closure has three basic components, namely, a sealing member30, an intraarterial anchor member 32, and a positioning member 34. Thesealing member is in the form of an elongated rod-like plug, e.g., ahemostatic, resorbable collagen sponge or foam. This member is arrangedfor sealing the puncture. The anchor member 34 is an elongated, stiff,low-profile, resorbable member which is arranged to be seated inside theartery against the artery wall contiguous with the puncture 24. Theanchor member 32 is made of non-hemostatic resorbable polymer similar toresorbable suture. The positioning member 34 comprises a filament, e.g.,a resorbable suture. The suture connects the anchor member and thecollagen plug (sealing member) via a pulley-like arrangement whichserves to move the anchor and plug together, to sandwich and lock theartery wall between the anchor and plug.

The closure device 22 is used after the interventional procedure isfinished. In particular, the physician inserts the delivery ordeployment instrument 20 containing the closure device 22 into thepatients' introducer sheath 28. On insertion, the anchor member 32passes out of the distal end of the introducer sheath and deploys intothe artery lumen. The deployment instrument 20 is then withdrawn fromthe introducer sheath until resistance is felt when the anchor membercatches on the distal end thereof. Once this occurs (and assuming thatthe anchor is in the correct orientation when it catches on the end ofthe introducer sheath, as will be described later) the deploymentinstrument and the introducer sheath are then immediately withdrawntogether. This withdrawing action causes the anchor member 32 to engage(catch) on the artery wall contiguous with the puncture. Continuedwithdrawal of the instrument and introducer sheath causes thepulley-like configuration of the filament to pull the collagen plug 30toward the anchor member 32, thereby depositing the plug in the puncturetract 24A against the exterior of the artery contiguous with thepuncture. The pulling on the filament to bring the plug into engagementwith the puncture site also has the effect of deforming the plug into alarger diameter body to aid in holding it in place. Moreover, since theplug is formed of a compressed collagen it also expands automatically inthe presence of blood within the puncture tract when deployed, therebyfurther contributing to the plug's enlargement. The instrument 20 alsoincludes a tamper (to be described later) which is mounted on the sutureand which is slidable thereon. The deployment of the plug member alsoeffects the deployment of the tamper into the puncture tract proximallyof the plug member. The tamper is then used to gently compress and lockthe collagen plug on the outside of the artery.

The closure is now locked in place through the clotting of thehemostatic collagen plug and by spring tension (to be described later)on the filament 34 attached to the intraarterial anchor 32. Thus theartery wall is sandwiched between the collagen plug 30 and anchor 32.Within a few hours after deployment, the anchor 32 will be coated withfibrin and thus attached firmly to the arterial wall, therebyeliminating the possibility of distal embolization. After approximatelythirty days, only a small deposit of anchor material will remain. Infact, resorption of all components will have occurred afterapproximately sixty days.

The anchor member 32 is non-hemostatic and is sized to behemodynamically insignificant in comparison to the size of the femoralartery. Thus, the resorbable anchor has an insignificant hemodynamiceffect on blood flow.

As will be appreciated by the description to follow deployment of theclosure device 22 by the instrument 20 is easy, quick and reliable.Anchoring is repeatable, safe, and effective to deploy the collagenplug. Hemostasis occurs almost instantaneously, e.g., in 15 seconds orless, when the closure device is deployed properly.

Referring now to FIGS. 2-5 the details of the closure device 22 will nowbe described. As can be seen in FIG. 2 the sealing member or plug 30comprises a cylindrical member formed of a compressible, resorbable,collagen foam, such as that sold by Collatec, Inc. of Plainsboro, N.J.The plug 30 is arranged to be compressed from the large diameterconfiguration shown in FIG. 2 to the small diameter, elongatedconfiguration shown in FIG. 3. In the configuration of FIG. 3 thediameter of the plug is very small, e.g., 1.32 mm, and therefor suitablefor disposition within the instrument 20 as will be described later. Theplug 30 includes an annular recess 40 extending about its outerperiphery adjacent its proximal end. Three apertures 42, 44, and 46extend through the plug. In particular, the aperture 42 is located closeto the recess 40 and diametrically through the centerline of the plug.The aperture 46 is located close to the distal end of the plug andextends transversely through the plug on one side of the centerline. Theaperture 44 is located between apertures 42 and 44 and extendstransversely through the plug on the other side of the centerline. Theseapertures serve as passageways through which the filament 34 extends toconnect the anchor member to the plug and are spaced apart to precludetearing of the plug.

The manner of connection of the plug to the anchor will be describedlater. Suffice it for now to state that the filament 34 of the closuredevice 22 serves to couple the plug component to the anchor component inan arrangement to effect the movement of the plug component toward theanchor component, once the anchor component is in its desired positionin the artery at the puncture or incision. In particular the coupling ofthe plug component to the anchor component simulates a pulley to achievea desired mechanical advantage.

In accordance with a preferred embodiment of this invention the filamentis formed of resorbable, flexible, strong material, e.g., a resorbablesuture.

As can be seen in FIGS. 4 and 5 the anchor member 32 basically comprisesa thin, narrow, strip or bar of material, such as a resorbablelactide/glycolide polymer sold by Medisorb Technologies InternationalL.P. under the trade designation MEDISORB. The strip is sufficientlyrigid such that once it is in position within the artery (as will bedescribed later) it is resistant to deformation to preclude it frombending to pass back through the puncture through which it was firstintroduced. The member 32 has a generally planar top surface 48, agenerally planar bottom surface 50 and a peripheral side surface 52.Each end of the member 32 is rounded. The side surface 52 of the anchormember 32 tapers inward from its top surface to its bottom surface asshown in FIG. 5 to facilitate the removal of the plug from the mold formaking it. A hemispherical projection 54 is located at the center of thetop surface 48. The hemispherical projection 54 includes alongitudinally extending slot 56 disposed perpendicularly to the topsurface 48 of the member 32. The bottom 58 of the slot 56 is arcuate(FIG. 5). A cylindrical opening 60 extends transversely across themember 32 through the projection 54. A loop 62 of suture materialextends through the opening 60. The loop 62 is closed by a knot 64. Theportion of the loop 62 extending through the opening 60 overlies thebottom 58 of the slot and forms a "pin" about which the filament 34extends. In particular the filament 34 is threaded through the slot 56,under the "pin" of the loop 60 and back out the slot 56 on the otherside thereof as shown clearly in FIG. 5 to connect the plug member 30 tothe anchor member 32.

In this regard the pulley-like connection between the anchor member andthe plug member is effected by threading the filament 34 from a remotepoint (which is located outside the deployment instrument 20 when theclosure device is in place in that instrument) through the transverseaperture 42, down the plug to the aperture 46, through that aperture tothe opposite side of the plug and from there to the anchor member whereit is threaded through the slot 56 and about the "pin" as describedearlier. From there the filament 34 extends back to the plug where itenters into aperture 44, passes through the aperture to the oppositeside of the plug, where it terminates in a loop 66 extending around theannular recess 40. The loop is secured by a knot 68, whose details areshown in FIG. 6.

In FIGS. 34 and 35 there is shown an alternative anchor member 32'. Thatanchor member is virtually identical to the anchor member 32 except thatmember 32' includes means to enable it to be imaged radiographically tofacilitate the placement of the closure at the desired situs within thepatient's body. Thus, as can be seen therein the alternative anchormember 32' includes a pair of wells 32A in the top surface 48 adjacentthe respective ends of the anchor member. A plug or powder of aconventional radio-opaque material, which is preferably biocompatibleand which is excretable, e.g., solid agents of sodium diatrizoate,iohexal, etc., is located within each well 32A. A respective cover orcap 32B, preferably formed of a thin disk of a bioresorbable material,e.g., PGA, is disposed over each well to seal the material within thewell. Each cover is secured to the top surface 48 of the anchor 32' by aseal line extending about the periphery of the well. That seal line canbe formed in various ways, e.g., by heat sealing.

Referring now to FIGS. 1 and 11 the details of the deployment instrument20 will now be described. As can be seen the instrument basicallycomprises a carrier 100 in the form of an elongated tube 102 formed of asomewhat flexible material, such as polyethylene or polyvinyl chloride,so that the carrier may be freely passed through the introducer sheathinto an operative position within the patient's artery, notwithstandingany curvature of the introducer sleeve which may exist.

In accordance with a preferred embodiment of this invention the outsidediameter of the tubular carrier 100 is 8 French. The distal end of thetube 102 includes a rigid, e.g., stainless steel, sleeve or bypass tube104 mounted thereon, to enable it to be inserted through a conventionalhemostasis valve 28A (FIGS. 12-14) forming a portion of the introducersheath 28, through the sheath, and out the distal end thereof into theartery 26. The distal end of the flexible tube 102 necks down into agenerally hemicylindrical configuration (See FIG. 1) which includes alongitudinally extending slit (not shown) therein to enable it to be fitwithin the bypass tube 104 without buckling.

As can be seen in FIG. 11, the closure device 22 is located within thedistal end of the tubular carrier 100. In particular the anchor member32 is disposed longitudinally within the bypass tube 104 laterally ofthe central longitudinal axis 106 of the carrier. The plug member 30 islocated within the tube 102 just behind (proximally) of the anchormember and on the opposite side of the central longitudinal axis. Infact the distal end of the plug member overlies the proximal end of theanchor member. The bypass tube 104 includes a reference detent 108 inits periphery located diametrically opposite to the position of theanchor member. The detent 108 serves as a visual guide to help the userorient the instrument to a proper yaw angle with respect to the centrallongitudinal axis for insertion within the introducer sheath as will bedescribed later.

As can be seen in FIGS. 1 and 11, the instrument 20 includes aconventional luer fitting 110. The proximal end of the carrier tube 102extends into an opening in the fitting 110 and is secured in placetherein by any suitable means. Another conventional luer fitting 112 isthreadedly secured to the threaded distal end 114 of the fitting 110.The fittings 110 and 112 together form a hollow body through which theproximal end of the filament 34 extends. A tensioning assembly islocated within that body and basically comprises a ball 116, a cupshaped ball seat 118, a compression spring 120, and a spring seat 122.The spring seat is a disk-like member located within an annular recesswithin the center of the luer fitting 110. The ball seat includes aconical inner surface 124 having a central opening 126. The spring is ahelical member interposed between the spring seat 122 and the ball 116to bias the ball toward the conical surface 124 of the ball seat 118.The proximally located portion of the filament 34 extends through thespace between the ball 116 and its seat. The amount of force applied tothe ball is established by a spacer sleeve 128 located between the luerfittings 110 and 112. By appropriate selection of the width of thesleeve 128 any desired preload can be applied to the spring.

As will be appreciated by those skilled in the art the tensioningassembly just described will tend to hold the filament in place withrespect thereto until the force applied to the filament exceeds thepreload force applied by the compression spring, whereupon the filamentwill be freed to slide through the instrument.

The carrier 100 also includes a tamping member 130. This member is anelongated rod-like member formed of any suitable material, e.g.,polyethylene, and is disposed within the carrier tube 102 immediatelyproximally of the plug 32. The tamping member 130 includes a centralpassageway 132 extending down its length from its distal end 134 to itsproximal end 136. The filament 34 portion extending from the anchormember 32 passes through the passageway 132 in the tamping member andfrom there into the luer fittings 110 and 112, past the tensioningassembly, and out through the hole 126 at the proximal end of theinstrument 20. A holding sleeve or tag 138, e.g., a stainless steeltube, is crimped onto the filament so that it engages the proximal endof the tamping member 130 to hold that member in place. The tag 138 isarranged to cooperate with a torsion spring 142 (FIGS. 9 and 10) toapply tension onto the filament 34 after the closure device is in placeto enable the instrument 20 to be removed and the filament severed (aswill be described later).

As mentioned earlier the instrument 20 is arranged to be inserted into aconventional introducer sheath 28 to effect the deployment of theclosure device 20. Before describing that operation a brief descriptionof the introducer sleeve and its method of location with respect to thepercutaneous puncture is in order. As can be seen in FIGS. 12-14 thesheath 28 includes a body portion in which a conventional hemostasisvalve 28A is located and a tubular portion 28B extending from the body.The tubular portion 28B terminates in an open distal or free end 28C.The body portion of the sheath 28 includes a sideport 28D having aconventional stopcock 28E located therein. The distal end of the body ofthe sheath includes an annular groove 28F which is arranged to receive aposition indicator clip 150 forming a portion of the system of thisinvention, for reasons to be described later.

Before the instrument can be inserted into the introducer sheath 28, thesheath itself must be properly located within the artery. This action isaccomplished via a positioning device 200. That device forms a portionof the system of this invention and is shown in FIGS. 7 and 8. As can beseen the device 200 basically comprises a conventional dilator whoseouter periphery has been modified to include a longitudinally extendingflat 202. The device 200 is arranged to be fully inserted within theintroducer sheath 28 like shown in FIG. 12. The insertion of the device200 within the introducer sheath 28 forms a passageway between theflatted surface 202 of the device 200 and the interior surface of thetubular portion 28B of the sheath disposed thereover. The length of theflatted portion 202 is selected so that when the device 200 is fullywith the introducer sheath, and the distal end of the sheath within theinterior of the artery, the distal end of the flatted surface extendsjust beyond the distal end 28C of the introducer sheath to form a window204 into which blood may flow, while the proximal end of the surface 202is in fluid communication with the interior of the introducer body andthe sideport 28D. Accordingly, blood may flow into the window 204through the passageway formed by the flatted surface, into the sideport28D and from there to the stopcock 28E when the window 204 is within theinterior of the artery.

In order to correctly position the introducer sheath the location of theartery wall must be established. This is accomplished by inserting thedevice 200 within the introducer sheath as just described and thenopening the stopcock 28E to observe the flow of blood therefrom. Theblood will normally flow out of the opened stopcock by virtue of thepressure differential across the lumen wall. If however, there isinsufficient pressure to cause such a flow of blood some means (notshown) can be used to create the desired differential pressure, e.g.,suction can be used. In any event once the flow of blood is observed theintroducer sheath with the device therein is then retracted (movedproximally) until the blood flow through the stopcock just stops, aposition shown in FIG. 13. This indicates that the distal end 28C of theintroducer sheath has just left the artery lumen. The introducer sheathwith the device therein is then reinserted approximately 10 mm into thepuncture to ensure that the distal end of introducer sheath is at thedesired position within the artery. Blood flow should be reestablishedthrough the stopcock at this time. Then the stopcock is closed. Fromthis point the introducer sheath must be kept fixed, i.e., it must notmove axially relative to the patient. To achieve that end the user ofthe system should provide a continuous grasp on the introducer sheath,with the patient's groin as a position reference. The positionindicating device 200 is then removed from the introducer sheath toready the introducer sheath for receipt of the deployment instrument 20carrying the closure device 22 as will be described later.

In FIG. 26 there is shown a second embodiment of a positioning device300 for effecting the proper positioning of the introducer sheath 28within the artery. As can be seen the device 300 basically comprises aconventional obturator whose outer periphery has been modified toinclude an annular recess 302 extending thereabout. Like the device 200,the device 300 is arranged to be fully inserted within the introducersheath 28 as shown in FIG. 27. The insertion of the device 300 withinthe introducer sheath 28 forms an annular passageway between the annularrecess 302 of the device 300 and the interior surface of the tubularportion 28B of the sheath 28. A side opening or port 304 is provided inthe sidewall 28B of the introducer sheath 28 closely adjacent its opendistal end 28C.

The length of the annular recess 302 is selected so that when the device300 is fully with the introducer sheath 28, and the port 304 in thedistal end of the sheath is located within the interior of the artery,the distal end of the annular recess 302 extends just beyond the port304 while the proximal end of the recess 302 is in fluid communicationwith the interior of the introducer's sideport 28D.

The port 304 forms a window into which blood in the artery may flow whenthe distal end 28C of the introducer is located therein. In particular,blood may flow into the window 304 through the annular passageway formedbetween the recess 302 and the inner surface of the tubular portion 28Aof the introducer, into the sideport 28D and from there to the stopcock28E when the window 304 is within the interior of the artery.

In FIG. 28 there is shown a third embodiment of a positioning device 400for effecting the proper positioning of the introducer sheath 28 withinthe artery. As can be seen the device 400 basically comprises aconventional obturator having a passageway 402 extending longitudinallydown substantially the length of the device. An entrance port 404extends radially inward into the device communicating with the distalend of the passageway 402, while an outlet port extends radially inwardinto the device communicating with the proximal end of the passageway402. Like the devices 200 and 300, the device 400 is arranged to befully inserted within the introducer sheath 28 as shown in FIG. 29.

The length of the annular passageway 402 is selected so that when thedevice 400 is fully with the introducer sheath 28 and the distal end ofthe sheath is located within the interior of the artery, the inlet port404 of the passageway 402 extends just beyond the free end of thesheath, while the outlet port 406 is in fluid communication with theinterior of the introducer's sideport 28D. The port 404 forms a windowinto which blood in the artery may flow when the distal end 28C of theintroducer is located therein.

In FIG. 31 there is shown alternative embodiment 28' of an introducersheath. The sheath is similar to sheath 28 described earlier except thatits tubular portion 28B includes a second passageway 502 (FIG. 31)extending therethrough. The passageway 502 serves as the passageway forblood to flow therethrough so that the sheath 28', itself, can act as apositioning device for effecting its proper positioning within theartery. As can be seen in FIG. 31 the passageway 502 extendslongitudinally down the sheath 28' within its wall and parallel to thecentral passageway 504 (the central passageway receives the deploymentinstrument 20--to be described later). The distal end of the passageway502 includes a radially extending port 506. The proximal end of thepassageway 502 (not shown) is in fluid communication with the interiorof the introducer's sideport 28D. The introducer sheath 28' is arrangedto be used with a conventional obturator 600 (shown in FIG. 30).

The positioning of the introducer sheath 28 utilizing either of thedevices 300 or 400 or the positioning of the introducer sheath 28'utilizing the obturator 600 is similar to that described with referenceto the device 200. Thus, after the introducer sheath is positioned asdescribed earlier the stopcock 28E is opened to observe the flow ofblood therefrom (thereby indicating that the inlet port or window iswithin the artery). The introducer sheath is then retracted (movedproximally) until the blood flow through the stopcock just stops,thereby indicating that the distal end 28C of the introducer sheath hasjust left the artery lumen. The introducer sheath with the devicetherein is then reinserted approximately 10 mm into the puncture toensure that the distal end of introducer sheath is at the desiredposition within the artery. Blood flow should be reestablished throughthe stopcock at this time. Then the stopcock is closed. From this pointthe introducer sheath must be kept fixed (as described earlier) and theposition indicating device 300 or 400 (or the conventional obturator600) removed to ready the introducer sheath for receipt of thedeployment instrument 20 carrying the closure device 22 through thecentral passageway in the particular introducer sheath (that passagewayis denoted by the reference number 504 in the embodiment 28').

The deployment of the closure will now be described with reference toFIGS. 14-23 and is as follows: The reference detent 108 on the bypasstube is identified by the user and the bypass tube grasped by the userand oriented so that the detent faces up (away from the patient) asshown in FIG. 14. This ensures that the anchor member is located towardsthe patient. The bypass tube is then inserted into the sheath throughthe hemostasis valve 28A. The rigid nature of the bypass tubefacilitates the passage of the carrier 100 through the hemostasis valveand also protects the closure device from damage. The instrument is thenpushed fully down the introducer sheath so that a stop surface 110A onthe front (distal) luer fitting 110 (FIG. 11) engages the body of theintroducer sheath housing the hemostasis valve. At this time the distalend of the carrier will be in the position shown in FIG. 16 and theanchor member 32 will be located in the artery 26 beyond the distal endof the introducer sheath. The bypass tube 104 remains within the portionof the introducer sheath housing the hemostasis valve 28A.

The position indicator clip 150 is then mounted onto the annular recess28F on the introducer sheath 28 as shown in FIG. 17. As can be seen inFIG. 25 the clip 150 includes a linear section 150A from which a yoke150B projects perpendicularly. The yoke 150B includes a circular mouth150C for receipt of the annular recess 28F of the introducer sheath.When mounted in place on the introducer sheath the free end 150D of theindicator clip will extend beyond the distal end of the instrument 20(beyond the tensioner assembly).

The system 20 is then operated to determine if the anchor member 32 hasbeen properly deployed. To that end the introducer sheath is then heldby the user to prevent axial movement and the instrument 20 is carefullywithdrawn from it. This action causes the anchor member 32 to engage orcatch on to the distal end of the introducer. As the anchor membercatches on the distal end of the introducer, resistance will be felt bythe user. This resistance must be noted by the time the luer fitting 112housing the tensioner assembly reaches the free end 150D of theindicator clip 150 as shown in FIG. 18. If so, then the anchor memberwill have caught on the distal end of the introducer at the location ofits hemispherical projection 54 (the desired occurrence).

If, however, no resistance is noted by the time that the luer fitting112 passes (extends proximally of) the free end of the indicator clip,this will indicate that the anchor has re-entered the introducer sheath,and that the anchor will not catch onto the artery as required. Thus, ifno resistance is felt at this point, the instrument 20 must bereinserted within the introducer sheath and the foregoing procedureretried, this time by turning the instrument 20 about its axis 106 by1/4 turns to each side before it is again withdrawn.

If the resistance is felt before the luer fitting reaches the free endof the indicator clip this will indicate that one of the curved ends ofthe anchor member has caught on the free end of the introducer sheath,an undesired occurrence. Accordingly, the instrument 20 must bewithdrawn then reinserted within the introducer sheath and the foregoingprocedure retried, this time by turning the instrument 20 about its axis106 by 1/4 turns to each side before it is again withdrawn.

Once the anchor member has been properly deployed, as shown in FIG. 18,the collagen plug is deployed. To that end the introducer sheath 28 andthe instrument 20 are held together and withdrawn as a unit from thepuncture, whilst swinging the unit toward the vertical as shown in FIG.19. This action causes the anchor 32 to engage or catch onto the innersurface of the artery 26 contiguous with the puncture 24. The introducersheath and the instrument are pulled further outward as shown in FIG.20. Inasmuch as the anchor member is trapped against the interior of theartery wall the continued retraction of the introducer sheath andinstrument causes the filament 34 to pull the collagen plug out of thecarrier tube 102 and into the puncture tract 24A. As the introducer andinstrument come out of the puncture tract, continuous steady resistancewill be felt as the tensioner assembly described heretofore controls theforce on the filament 34 during the retraction procedure. Continuedretraction of the introducer and the instrument brings the tampingmember 130 out of the free end of the instrument.

Moreover the pulley arrangement of the filament 24 connecting the anchormember and the plug member ensures that during the retraction of theintroducer and the instrument the plug member is moved into engagementwith the exterior of the artery wall contiguous with the puncture 24. Infact continued retraction causes the filament to somewhat deform theplug, i.e., cause it to deform radially outward. The existence of bloodwithin the puncture tract further contributes to the deformation of theplug member since the collagen foam expands in the presence of blood.

The retraction procedure continues to pull the introducer and instrumentup the filament until the tag 138 is exposed as shown in FIG. 22. Atthis point the anchor member and collagen plug member have beendeployed. At this time the collagen plug is tamped by the tamping member130. In particular the user quickly compacts the collagen of the plug bygently tensioning the filament by pulling on the introducer sheath andinstrument in the proximal direction with one hand. The tamping memberis then manually slid down the filament by the user's other hand so thatit enters the puncture tract 24A and engages the proximal end of theplug member 32. A few gentle compactions are adequate to achieve thedesired result, i.e., to assist the plug member 30 to conform to theartery contiguous with the puncture and to assist to lock the plug inplace until hemostasis occurs (which happens very quickly, therebylocking the closure in place). It should be noted that during thetamping action care must be taken to maintain tension on the filament 34at a load greater than that used on the tamping member 130 to ensurethat the tamping action doesn't propel the plug member 30 into theinterior of the artery.

After the tamping action is completed the torsion spring 142 is mountedon the filament 34 as shown in FIG. 23. This action is necessary tomaintain appropriate tension on the filament while the instrument 20 isremoved (the filament severed). In FIGS. 9 and 10 the torsion spring isshown. As can be seen therein the spring 142 includes a pair of legs142A and 142B projecting outward from a helical central section 142C.Each leg includes a slot 142D at its free end. One of the slots isarranged to receive the filament 34 therein and to engage the tag 138.The other of the slots is arranged to receive the filament 34 thereinand to engage the proximal end of the tamping member 130. The legs 142Aand 142B are biased by the intermediate section 142C so that when thespring is mounted on the filament as just described they will bias thetamping means towards the plug member 30 to hold it in place so that thefilament can be severed (as is necessary to remove the instrument andthe introducer from the closure device). Thus, once the spring is inplace the filament on the proximal side of the tag 138 is cut and thespring applies a light controlled pressure to the collagen plug andanchor. The closure is left in this condition without being disturbedfor approximately 30 minutes. After that time the spring 142 is removedand the filament is then severed at the top of the tamping member 130.The tamping member 130 is then removed and the remaining portion of thefilament is taped to the skin at 160 as shown in FIG. 24. The tape (notshown) should be removed and the filament cut subcutaneously prior tothe discharge of the patient.

With the closure in final position as shown in FIG. 24 the anchor member32 (the only portion within the artery) does not take up a substantialportion of the interior of the artery and thus does not block off orotherwise impede the flow of blood therethrough. Since the components ofthe closure are all formed of resorbable materials the closure can beleft in place within the body until it is absorbed.

In FIG. 36 there is shown an alternative embodiment 700 of tamping meansconstructed in accordance with this invention. The tamping means 700basically comprises an assembly of two components, whereas the tampingmeans 130 described earlier is composed of only a single component.Thus, as can be seen in FIG. 36 the assembly 700 comprises a firsttubular component 702 and a second tubular component 704. The component702 includes a central passageway 706 and is formed of any suitablematerial, e.g., the same material as used to form the tamping component130 described earlier. The second component 704 also includes a centralpassageway 708 extending therethrough.

The component 704 is mounted on the front or distal end of the component702. To that end the component 704 includes an annular recess 710 aboutits periphery at the proximal end thereof. This recess is arranged toreceive the distal end 712 of the component 702, with the twopassageways 706 and 708 axially aligned to enable the filament 34 toextend therethrough.

The component 704 is preferably formed of a compressed collagen foam,e.g., the same type of material used for the sealing portion or plug 30of the closure. The distal end 714 of the component 704 is arranged toengage the plug 30 to tamp it down in the same manner as thataccomplished by the distal end 134 of tamping member 130. Once thetamping action is completed the torsion spring 142 is mounted on thefilament as shown in FIG. 37 so that it is located between the tag 138and the proximal end of the component 702 (in the same manner asdescribed with respect to tamping member 130 shown in FIG. 23). Thus,the filament on the proximal side of the tag 138 can be cut, while thespring applies light controlled pressure to the collagen plug 30 andanchor 32. The closure is left in this condition in the same manner asdescribed earlier after which time the spring is removed and thefilament severed at the top (proximal end) of the tamping component 702.That component can then be removed, leaving the tamping component 704within the puncture tract as shown in FIG. 38. The remaining (exteriorlyextending) portion of the filament is taped to the skin at 160 as alsodescribed earlier.

As should be appreciated by those skilled in the art the two sections ofthe filament 34 between the anchor component 32 and the plug component30 effectively form a "pulley" arrangement to increase the mechanicaladvantage of the force applied to the filament to move the twocomponents toward each other. Accordingly, the closure can be properlyseated without the application of a high pulling force. The use of thebiased ball and associated seat between which the filament passes duringthe placing of the closure ensures that irrespective of how hard theinstrument and the introducer are withdrawn from the puncture during thedeployment and seating of the closure, the amount of force applied tothe filament 34, and hence to the closure device, will not exceed apredetermined maximum, e.g., one pound. This feature is of considerableimportance to ensure that the anchor portion of the closure is notpulled through the opening (e.g., incision or puncture) once it is inplace.

As should also be appreciated from the foregoing, the closure device,the instrument for deploying it, and their method of use enables theready, effective and efficient sealing of a percutaneous puncture in anartery. Thus, it is expected that the hemostatic puncture closure device20 will be a significant advancement in the fields of cardiology andradiology. The device may allow continuance of anticoagulationpost-procedure, more aggressive use of thrombolytic agents and safer useof large bore catheters. It should also reduce discomfort andcomplication rates for patients; allow many in-patient procedures to beperformed safely on an out-patient basis; decrease the time and cost ofinterventional procedures; and reduce exposure of hospital personnel tohuman blood.

Without further elaboration the foregoing will so fully illustrate ourinvention that others may, by applying current or future knowledge,adopt the same for use under various conditions of service.

What is claimed is:
 1. A closure assembly for sealing a percutaneousincision or puncture in the wall of a vessel, duct, lumen or holloworgan in the body of a living being, wherein the incision or punctureincludes a tract extending from the opening in the wall of the vessel,duct, lumen or hollow organ to the skin of the being, the tract havingan inner surface, said closure assembly comprising a first member formedof a bioabsorbable material and configured for passage through theopening in the vessel, duct, lumen or hollow organ to the interiorthereof, a second member arranged to be extended proximally into thetract from said first member and having a greater flexibility than saidfirst member for holding said first member at a desired position withinthe interior of the vessel, duct, lumen or hollow organ, and a thirdmember separate from said first member and in the form of a mass of abioabsorbable, material which is arranged for introduction in a firststate into the puncture tract without entering into the vessel, duct,lumen or hollow organ and being movable within the tract along saidsecond member relative to said first member when said first member islocated within the vessel, duct, lumen or hollow organ, whereupon saidthird members extends along said second member and proximally of thewall of the vessel, duct, lumen or hollow organ to engage the innersurface of the tract along at least a portion of the length of thetract, said mass being alterable within tract to a second state, whereinsaid mass in said second state conforms to the shape of the portion ofthe tract in which it is located and substantially fills that portion ofthe tract, while cooperating with said first member to seal the incisionor puncture from the flow of a fluid therethrough.
 2. The closure ofclaim 1 wherein said third member is alterably deformable to be deformedwithin the puncture tract to cooperate with said first members to sealthe incision or puncture from the flow of fluid therethrough.
 3. Theclosure of claim 1 wherein said third member is formed of collagen andis arranged to be deformed by the application of a tamping forcethereto.
 4. The closure of claim 1 wherein said first member comprisesan anchor and wherein said second member comprises a filament.
 5. Theclosure of claim 3 wherein said first member comprises an anchor andwherein said second member comprises a filament.
 6. The closure of claim4 wherein said second member connects said first and third members in apulley like arrangement.
 7. The closure of claim 5 wherein said secondmember connects said first and third members in a pulley likearrangement.
 8. The closure of claim 1 wherein said first memberincludes radio-opaque means.
 9. The closure of claim 4 wherein saidfirst member includes radio-opaque means.
 10. The closure of claim 1wherein said third member is formed of a hemostatic material.
 11. Theclosure of claim 1 wherein said third member is formed of a materialthat is alterable from said first state to said second state in responseto conditions within the tract.
 12. The closure of claim 11 wherein saidthird member is formed of a material that is alterable from said firststate to said second state in response to fluid within the tract. 13.The closure of claim 1 wherein said third member is formed of a materialthat is alterable from said first state to said second state in responseto the application of a mechanical force thereto.
 14. The closure ofclaim 13 wherein said third member is formed of a material that isalterable from said first state to said second state in response to theapplication of a tamping force thereto.
 15. The closure of claim 10wherein said third member is formed of a material that is alterable fromsaid first state to said second state in response to conditions withinthe tract.
 16. The closure of claim 15 wherein said third member isformed of a material that is alterable from said first state to saidsecond state in response to fluid within the tract.
 17. The closure ofclaim 10 wherein said third member is formed of a material that isalterable from said first state to said second state in response to theapplication of a mechanical force thereto.
 18. The closure of claim 17wherein said third member is formed of a material that is alterable fromsaid first state to said second state in response to the application ofa tamping force thereto.